510(k) Report

Devices descending from K082369

4 later devices reach Cadence, Cadence Dual, Cadence II Fetal Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102140Fetal Monitors, Models F2 and F3Edan Instruments, Inc.201131
+2K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+2K141194FM-3000 Fetal MonitorAdvanced Instrumentations, Inc.20140—
+3K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—